The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0435-2020·Announced 2019-11-27

Altaire Pharmaceuticals Recalls iSolutions Nano Tears XP Due to Sterility Concerns

Altaire Pharmaceuticals is recalling iSolutions Nano Tears XP eye drops because the company cannot guarantee the product is sterile.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II. According to the rubric, FDA Class II recalls with potential for adverse health consequences (such as loss of sterility in a sterile product) are categorized as Severe (Score 4), as they are not Class I (Critical) but involve significant risk.

Plain-English summary

Altaire Pharmaceuticals, Inc. is voluntarily recalling iSolutions Nano Tears XP Clear Emollient Lubricant Gel Drops Moderate Sterile, 1/3 FL OZ (10 mL). The recall was initiated because the manufacturer lacks assurance of the product's sterility. The affected product is identified by NDC 59390-143-10 and includes lot codes 17366 12/19, 18103 /20, and 18173 7/20.

The recall covers 12,716 units distributed nationwide in the United States. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

Consumers who have purchased this product should stop using it and contact Altaire Pharmaceuticals, Inc. for further instructions or a refund. The recall is being conducted to ensure patient safety and compliance with FDA regulations regarding sterile medical products.

The recalled product

Product
iSolutions Nano Tears XP Clear Emollient Lubricant Gel Drops Moderate Sterile, 1/3 FL OZ (10 mL), Mfd. By: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390-143-10
Manufacturer
Altaire Pharmaceuticals, Inc.
Category
Drug — Ophthalmic
Hazard
Affected units
12,716

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • 17366 12/19 18103 /20 18173 7/20

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 134 recalled by Altaire Pharmaceuticals, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 134 products in this recall →

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